3.2.S.2.4 - Controls of Critical Steps and Intermediates

Critical steps:

Tests and acceptance criteria, with justification including experimental data, performed at critical steps identified in the sequential procedural narrative should be provided.

Intermediates:

The specification and analytical methods of isolated intermediates should be provided.

• The specification of intermediates should be justified and should include, as applicable, tests for specified and unspecified impurities, total impurities, solvents, catalysts, elemental impurities and mutagenic impurities.

For non-isolated intermediates, tests and parameters used to determine reaction end-points should be provided or their absence justified.